Skin and Soft Tissue Infections
Research on complicated skin and skin structure infections (cSSSI) including cellulitis, abscesses, wound infections, and surgical site infections caused by gram-positive bacteria.
Quick Answer
What it is
Research on complicated skin and skin structure infections (cSSSI) including cellulitis, abscesses, wound infections, and surgical site infections caused by gram-positive bacteria.
Key findings
- Grade A: Clinical Cure Rate (Oritavancin (Orbactiv))
- Grade A: MRSA Efficacy (Oritavancin (Orbactiv))
- Grade A: Early Clinical Response (Oritavancin (Orbactiv))
Safety
- Pooled safety (n=1959): Adverse events 55.3% vs 56.9% vancomycin.
- No renal toxicity advantage over vancomycin in ABSSSI.
- Avoid in moderate-severe renal impairment unless benefit outweighs risk.
ℹ️ Quick Facts
Quick Facts: Skin and Soft Tissue Infections
- Supplements Studied:4
4 supps · 13 outcomes
Detailed Outcomes
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A
Clinical Cure Rate
SOLO-1 & SOLO-2 pooled (n=1987): Primary composite endpoint 81.2% oritavancin vs 80.9% vancomycin (noninferior). Investigator-assessed clinical cure 81.2% vs 80.2%. Single dose noninferior to 7-10 day vancomycin. NCT01252719, NCT01252732.
none
A
MRSA Efficacy
SOLO trials (n=405 MRSA): ≥20% lesion size reduction 93.1% oritavancin vs 87.1% vancomycin (difference 6.1%, P=0.032). Statistically superior to vancomycin for MRSA infections specifically.
small↑Improves
A
Early Clinical Response
≥20% lesion area reduction at 48-72h: 86.4% oritavancin vs 84.1% vancomycin. Met FDA-required early clinical response endpoint. Enables outpatient treatment with single hospital visit.
none
A
Safety Profile
Pooled safety (n=1959): Adverse events 55.3% vs 56.9% vancomycin. Serious AEs 5.8% vs 5.9%. Common: nausea, headache, vomiting. Infusion-related reactions ~3%. No renal toxicity advantage over vancomycin in ABSSSI.
none
A
Clinical Cure Rate - cSSSI
ATLAS-1 & ATLAS-2 Phase 3 (n=1794): Clinical cure rate 88.3% telavancin vs 87.1% vancomycin in clinically evaluable patients. Noninferior to vancomycin for complicated skin and skin structure infections including MRSA.
none
A
Nephrotoxicity Risk
SAFETY CONCERN: Higher mortality in patients with pre-existing renal impairment (CrCl <50 mL/min). Avoid in moderate-severe renal impairment unless benefit outweighs risk. Monitor renal function closely. Dose adjust for CrCl <50.
moderate↑Worsens
A
Clinical Cure Rate
DISCOVER-1 & DISCOVER-2 pooled (n=1289): Clinical success 79.7% dalbavancin vs 79.8% vancomycin/linezolid (noninferior). Two-dose regimen: 1000 mg day 1, 500 mg day 8. Single-dose 1500 mg also approved. NCT01339091, NCT01431339.
none
A
Early Clinical Response (48-72h)
≥20% reduction in lesion area at 48-72h: 83.3% dalbavancin vs 81.8% comparator. Met FDA-required early clinical response endpoint. Among first trials to use new early primary efficacy endpoints.
none
A
MRSA Efficacy
MRSA clinical success comparable to comparator. MIC consistently <0.125 µg/mL against MRSA. Bactericidal against VISA. No cross-resistance with other antibiotic classes.
none
A
Nephrotoxicity vs Vancomycin
Post-hoc safety analysis: Lower nephrotoxicity rates compared to vancomycin. No renal dose adjustment required for CrCl >30 mL/min. Less monitoring required than vancomycin due to weekly dosing and predictable PK.
moderate↓Improves
A
Clinical Cure - Skin Infections (cSSSI)
Pivotal Phase 3 trials (n=902): Clinical success 83.4% daptomycin vs 84.2% conventional therapy (noninferiority met). 4 mg/kg IV once daily for 7-14 days. Effective against MRSA (microbiologic success similar). Noninferior to vancomycin, penicillinase-resistant penicillins.
none
A
Myopathy/CPK Elevation
SAFETY CONCERN: CPK elevation >5x ULN in 2.8% of patients (vs 1.8% comparators). Myopathy/rhabdomyolysis reported. Weekly CPK monitoring recommended. Discontinue if CPK >1000 U/L with symptoms or >2000 U/L asymptomatic. Avoid concurrent statins when possible.
small↓Worsens
B
Eosinophilic Pneumonia Risk
SAFETY CONCERN: Rare but serious eosinophilic pneumonia reported (onset typically 2-4 weeks). Presents with fever, dyspnea, diffuse infiltrates, eosinophilia. Generally reversible upon discontinuation. Also inactivated by pulmonary surfactant - contraindicated for community-acquired pneumonia.
small↑Worsens
Research Citations (100)
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